Occlusion Detection Dressing Kit
FDA 510(k) K171499 · Cardinalhealth
510(k) numberK171499
Submission
- Device name
- Occlusion Detection Dressing Kit
- Applicant
- Cardinalhealth
Waukegan, IL, US - Received
- May 23, 2017
- Decision date
- September 22, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OMP – Negative Pressure Wound Therapy Powered Suction Pump
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Specialty
- General, Plastic Surgery
For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
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| K261338 | RENASYS DYNAFLOW Kit (66807741)OMP · Traditional | Smith & Nephew Medical, Ltd. | 09/11/2026SE |
| K253263 | ConvaVAC Negative Pressure Wound Therapy SystemOMP · Traditional | Convatec Limited, Gdc Building | 06/24/2026SE |
| K253199 | Curasys 2 (EMDN0003)OMP · Traditional | CG Bio Co., Ltd. | 06/23/2026SE |
| K260646 | Renasys Edge (66803126)OMP · Traditional | Smith & Nephew Medical, Ltd. | 05/27/2026SE |
| K261291 | Nisus NPWT Canister 500-mL (CPC-500)OMP · Special | Cork Medical | 05/21/2026SE |
| K254019 | Wound Geni NPWT SystemOMP · Traditional | Bechtel Medical, Inc. | 05/04/2026SE |
| K253429 | Genadyne ASTRA NPWTOMP · Traditional | Genadyne Biotechnologies, Inc. | 03/12/2026SE |
| K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam…OMP · Traditional | Deroyal Industries, Inc. | 11/21/2025SE |
| K251646 | extriCARE® 1000 Negative Pressure Wound Therapy SystemOMP · Traditional | Alleva Medical Devices | 10/03/2025SE |
| K251826 | RENASYS WOUND+ Dressing Kit with AIRLOCK TechnologyOMP · Traditional | Smith & Nephew Medical, Ltd. | 09/11/2025SE |
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| K213174 | Salem Sump Silicone Dual Lumen Stomach Tube with ENFit ConnectionPIF · Traditional | 05/19/2022SE |
| K202217 | Kendall NPWT Incision Management DeviceOMP · Traditional | 06/04/2021SE |
| K191101 | Kendall NPWT Incision Management Dressing KitOMP · Traditional | 07/31/2020SE |
| K190923 | Salem Sump Dual Lumen Stomach Tube with ENFit ConnectionPIF · Traditional | 11/07/2019SE |
| K161418 | Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery SetOMP · Traditional | 01/19/2017SE |
Questions and answers
When was Occlusion Detection Dressing Kit cleared by the FDA?
Occlusion Detection Dressing Kit (K171499) received a 510(k) decision of Substantially Equivalent on September 22, 2017, 122 days after the submission was received.
What is the product code of K171499?
The FDA product code is OMP – Negative Pressure Wound Therapy Powered Suction Pump, a Class II (moderate risk) device regulated under 21 CFR 878.4780.